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NCT02952092
A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia
Completed
Phase 3
Last updated 30 October 2024
What this trial tests
Phase 3 trial testing roxadustat in Hemodialysis Chronic Kidney Disease Patients With Anemia in 303 participants. Completed in 15 March 2018.
Timeline
30 November 2016
Primary endpoint
13 March 2018
13 March 2018
15 March 2018
Quick facts
| Lead sponsor | Astellas Pharma Inc |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 303 |
| Start date | 30 November 2016 |
| Primary completion | 13 March 2018 |
| Estimated completion | 15 March 2018 |
| Sites | 57 locations across Japan |
Drugs / interventions tested
- roxadustat (ROXADUSTAT) — full drug profile →
- Darbepoetin alfa (DARBEPOETIN ALFA) — full drug profile →
Conditions studied
- Hemodialysis Chronic Kidney Disease Patients With Anemia — all drugs for Hemodialysis Chronic Kidney Disease Patients With Anemia →
Sponsor
Astellas Pharma Inc — full company profile →
Who can join
20 and older, any sex, with Hemodialysis Chronic Kidney Disease Patients With Anemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to evaluate the safety and efficacy of ASP1517 compared to darbepoetin alfa in hemodialysis chronic kidney disease patients with anemia.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Phase 3, Randomized, Double-Blind, Active-Comparator (Darbepoetin Alfa) Study of Oral Roxadustat in CKD Patients with Anemia on Hemodialysis in Japan.
Akizawa T, Iwasaki M, Yamaguchi Y, Majikawa Y, et al · · 2020 · cited 156× · PMID 32493693 · DOI 10.1681/asn.2019060623 -
Hypoxia-inducible factor-prolyl hydroxylase inhibitors in the treatment of anemia of chronic kidney disease.
Haase VH. · · 2021 · cited 115× · PMID 33777492 · DOI 10.1016/j.kisu.2020.12.002 -
The hypoxia-adenosine link during inflammation.
Bowser JL, Lee JW, Yuan X, Eltzschig HK. · · 2017 · cited 90× · PMID 28798196 · DOI 10.1152/japplphysiol.00101.2017 -
A network meta-analysis of the efficacy of hypoxia-inducible factor prolyl-hydroxylase inhibitors in dialysis chronic kidney disease.
Chen J, Shou X, Xu Y, Jin L, et al · · 2023 · cited 21× · PMID 36988549 · DOI 10.18632/aging.204611 -
Factors affecting the doses of roxadustat vs darbepoetin alfa for anemia treatment in hemodialysis patients.
Akizawa T, Yamaguchi Y, Majikawa Y, Reusch M. · · 2021 · cited 20× · PMID 33200512 · DOI 10.1111/1744-9987.13609 -
A Novel Choice to Correct Inflammation-Induced Anemia in CKD: Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat.
Yan Z, Xu G. · · 2020 · cited 20× · PMID 32850902 · DOI 10.3389/fmed.2020.00393 -
Safe and Effective Treatment for Anemic Patients With Chronic Kidney Disease: An Updated Systematic Review and Meta-Analysis on Roxadustat.
Tang M, Zhu C, Yan T, Zhou Y, et al · · 2021 · cited 13× · PMID 34276361 · DOI 10.3389/fphar.2021.658079 -
Hypoxia-Inducible Factor Stabilizers in End Stage Kidney Disease: "Can the Promise Be Kept?"
Crugliano G, Serra R, Ielapi N, Battaglia Y, et al · · 2021 · cited 10× · PMID 34830468 · DOI 10.3390/ijms222212590
Verify or expand the search:
- PubMed search for NCT02952092
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of roxadustat
Trials testing the same drug.
- NCT02988973 — A Study of Intermittent Oral Dosing of ASP1517 in Non-Dialysis Chronic Kidney Disease Patients With Anemia · Phase 3 · completed
- NCT02964936 — A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia · Phase 3 · completed
- NCT02780726 — A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia · Phase 3 · completed
- NCT02780141 — A Study of Intermittent Oral Dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-Naive Hemodialysis Chronic Kidn · Phase 3 · completed
- NCT02779764 — A Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Con · Phase 3 · completed
Other Astellas Pharma Inc trials
Trials by the same sponsor.
- NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
- NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
- NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
- NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
- NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02952092 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
- Last refreshed: 30 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02952092.
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